On August 14, 2025 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported financial results and recent corporate highlights for the second quarter ended June 30, 2025 (Press release, Fortress Biotech, AUG 14, 2025, View Source [SID1234655301]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We achieved several key milestones in the second quarter that underscore the strength of Fortress’s diversified business model and our ability to create value across our portfolio. The acquisition of our subsidiary Checkpoint Therapeutics by Sun Pharma marked a significant validation of our business model, delivering approximately $28 million upfront, plus the potential for an additional contingent value right (CVR) payment and ongoing royalties on future sales of UNLOXCYT (cosibelimab-ipdl). We also look forward to the PDUFA goal date for CUTX-101, which is rapidly approaching on September 30, 2025 and the potential Priority Review Voucher which may be issued upon approval."

Dr. Rosenwald continued, "In addition, Mustang Bio received Orphan Drug Designation for MB-101, reinforcing the promise of our combination strategy leveraging MB-101 and MB-108 to target high-grade gliomas. Journey Medical continues to execute well, with the launch of Emrosi and commercial uptake, including expanded payer coverage now reaching 65% of U.S. commercial lives. We remain focused on unlocking the value of our portfolio and delivering innovative treatments to patients in need."

Recent Corporate Highlights1:

Monetization Updates

●On May 30, 2025, Fortress’ subsidiary, Checkpoint Therapeutics, Inc. ("Checkpoint"), was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, "Sun Pharma"). Fortress received ~$28 million shortly after closing and is eligible to receive up to an
1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private or public subsidiaries (referred to herein as "subsidiaries" or "partner companies") and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT (cosibelimab-ipdl).

Regulatory Updates

● The FDA accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a Prescription Drug User Fee Act ("PDUFA") goal date of September 30, 2025. In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Cyprium Therapeutics, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA Priority Review Voucher that may be issued at NDA approval.
● In July 2025, the FDA granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma. MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. We intend to advance MB-101, in combination with MB-108, as a potential treatment option. Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment ("TME") to make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.

Commercial Product Updates

● Journey Medical’s net product revenues for the second quarter ended June 30, 2025, were $15.0 million, compared to net product revenues of $14.9 million for the second quarter ended June 30, 2024.
● At the end of March 2025, Journey Medical announced initial distribution to pharmacies and first prescriptions filled for Emrosi for the treatment of inflammatory lesions of rosacea in adults. The full commercial launch began on April 7, 2025. Emrosi is available by prescription at specialty pharmacy chains.
● In July 2025, Journey Medical announced expanded payer access with over 100 million commercial lives in the United States for Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, 10mg immediate release and 30mg extended release), the Company’s recently launched treatment for the inflammatory lesions of rosacea in adults. This compares to 54 million commercial lives in May 2025.

Clinical Updates

● In June 2025, we announced that a data analysis from the two Phase 3 multicenter clinical trials evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults was presented at the Society of Dermatology Physician Associates 2025 Summer Dermatology Conference. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval.
● In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca is continuing to evaluate the full results and plans to share the data with health authorities and at a medical meeting.

General Corporate:

● Journey Medical joined the small-cap Russell 2000 Index and the broad-market Russell 3000 Index, effective after the close of U.S. equity markets on June 27, 2025, as a result of the 2025 annual Russell Index reconstitution.

Financial Results:

● As of June 30, 2025, Fortress’ consolidated cash and cash equivalents totaled $74.4 million, compared to $57.3 million as of December 31, 2024, an increase of $17.1 million year-to-date.
● Fortress’ consolidated cash and cash equivalents, totaling $74.4 million as of June 30, 2025, includes $38.1 million attributable to Fortress and the private subsidiaries, $3.3 million attributable to Avenue, $12.7 million attributable to Mustang Bio and $20.3 million attributable to Journey Medical. Checkpoint was acquired by Sun Pharma in May 2025.
o Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and included $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang and $20.3 million attributable to Journey Medical.
● Fortress’ consolidated net revenue totaled $16.4 million for the second quarter ended June 30, 2025, $15.0 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $14.9 million for the second quarter of 2024, most of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $8.1 million for the second quarter ended June 30, 2025, compared to $12.7 million for the second quarter ended June 30, 2024.
● Consolidated selling, general and administrative costs were $38.8 million for the second quarter ended June 30, 2025, compared to $20.8 million for the second quarter ended June 30, 2024.
● Consolidated net income attributable to common stockholders was $13.4 million, or $0.50 per share basic, and $0.45 per share diluted, for the second quarter ended June 30, 2025, compared to net loss attributable to common stockholders of $(13.3) million, or $(0.73) per share basic and diluted, for the second quarter ended June 30, 2024.

On August 14, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the second quarter ended June 30, 2025 (Press release, Xilio Therapeutics, AUG 14, 2025, View Source [SID1234655319]).

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"During the second quarter, we continued to make strong progress across our pipeline of novel tumor-activated immuno-oncology therapies, and with our recent financing, we believe that we are well-positioned to execute on our strategic goals," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We believe our masked T cell engager molecules have the potential to be best-in-class, and we anticipate nominating our first development candidates for our wholly owned programs later this year. In addition, we are very encouraged by the clinical progress for XTX301, our tumor-activated IL-12 advancing in partnership with Gilead, and we look forward to providing a program update in the near-term. We also recently reported updated Phase 2 combination data for vilastobart at ASCO (Free ASCO Whitepaper) and believe these data not only highlight the significant opportunity for vilastobart across a range of I-O combinations and tumor types, but also provide further clinical validation for our proprietary masking technology and approach."

Pipeline and Business Updates

Vilastobart: tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). Vilastobart is currently being evaluated in combination with atezolizumab (Tecentriq) in Phase 1C combination dose escalation in patients with advanced solid tumors and in a Phase 2 clinical trial in patients with metastatic microsatellite stable (MSS) colorectal cancer (CRC).

● In May 2025, Xilio announced promising updated Phase 2 data for vilastobart in combination with atezolizumab in patients with metastatic MSS CRC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated a preliminary 26% objective response rate in heavily pre-treated metastatic MSS CRC patients without liver metastases, including deep and durable responses accompanied by substantial decreases in tumor biomarkers and improvements in clinical symptoms, as well as a differentiated and well-tolerated safety profile with a low incidence of colitis and other immune-related adverse events, which have historically limited the potential for anti-CTLA-4 therapies. For more information, read the press release here. Xilio anticipates reporting additional data from the Phase 2 trial in the first half of 2026.

● Based on the encouraging clinical data to date, Xilio believes vilastobart has the potential to be an I-O combination agent of choice and be combined with a range of existing and next-generation agents. Xilio continues to engage strategic partners on potential opportunities to accelerate and expand further development for vilastobart.

XTX301: tumor-activated IL-12

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. (Gilead) related to Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is evaluating XTX301 as a monotherapy in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

● Xilio recently completed enrollment in Phase 1A monotherapy dose escalation and evaluation of those patients is ongoing. In addition, Xilio continues to enroll patients in Phase 1B monotherapy dose expansion of the ongoing Phase 1 clinical trial of XTX301.

XTX501: masked PD-1/IL-2 bispecific

XTX501 is a novel, tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

● Xilio is continuing to advance XTX501 in investigational new drug (IND)-enabling studies and plans to submit an IND application for XTX501 in the middle of 2026.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly owned programs targeting the tumor-associated antigens for PSMA, CLDN18.2 and STEAP1 and an additional program in collaboration with AbbVie.

Xilio’s masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and T cell activation.

● Xilio anticipates nominating development candidates for its PSMA program (ATACR format), CLDN18.2 program (ATACR format) and STEAP1 program (SEECR format) in the third quarter of 2025, fourth quarter of 2025 and first half of 2026, respectively.

● Xilio anticipates advancing at least two of these programs into initial IND-enabling studies and submitting IND applications for those programs in 2027.

Corporate Updates

● In June 2025, Xilio closed a follow-on public offering of prefunded warrants and accompanying common stock warrants and received initial gross proceeds of approximately $50.0 million before deducting underwriting discounts and commissions and offering expenses. In connection with the offering, Xilio issued Series B and Series C common stock warrants and will receive up to $100.0 million of additional gross proceeds by the second half of 2026 if all of those warrants are exercised in cash at their initial exercise price of $0.75 per warrant. The financing was co-led by new investors Coastlands Capital and Frazier Life Sciences and included participation from Gilead Sciences, Inc., Logos Capital, Samsara BioCapital and other new and existing institutional investors. For more information, read the press release here.

● In June 2025, Xilio announced the appointment of Akintunde (Tunde) Bello, Ph.D., to the company’s board of directors. For more information, read the press release here.

Second Quarter 2025 Financial Results

● Cash Position: Cash and cash equivalents were $121.6 million as of June 30, 2025, compared to $55.3 million as of December 31, 2024. In the second quarter of 2025, Xilio received $47.0 million in net proceeds from its June 2025 follow-on public offering after deducting underwriting discounts and commissions and offering expenses payable by the company.

● Collaboration and License Revenue: Collaboration and license revenue was $8.1 million for the quarter ended June 30, 2025, compared to $2.4 million for the quarter ended June 30, 2024. Collaboration and license revenue for the quarter ended June 30, 2025 consisted of revenue recognized in connection with Xilio’s collaborations with AbbVie and Gilead, and collaboration and license revenue for the quarter ended June 30, 2024 consisted of revenue recognized in connection with Xilio’s collaboration with Gilead.

● Research & Development (R&D) Expenses: R&D expenses were $15.3 million for the quarter ended June 30, 2025, compared to $11.2 million for the quarter ended June 30, 2024. The increase was primarily driven by increased clinical development activities related to vilastobart, increased costs related to early-stage programs and indirect research and development and increased personnel-related costs, which were partially offset by decreased costs related to clinical development activities for XTX202, a tumor-activated IL-2, as a result of discontinuing further investment in that program. For the quarter ended June 30, 2025, R&D expenses also included manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, which were not separately tracked for the quarter ended June 30, 2024 as the company had not yet begun performing IND-enabling studies. For the quarter ended June 30, 2024, R&D expenses also included a $1.0 million development milestone under the CTLA-4 monoclonal antibody license agreement with WuXi Biologics (Hong Kong) Limited for which there was no comparable cost for the quarter ended June 30, 2025.

● General & Administrative (G&A) Expenses: G&A expenses were $7.1 million for the quarter ended June 30, 2025, compared to $5.8 million for the quarter ended June 30, 2024. The increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, and an increase in personnel-related costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance.

● Net Loss: Net loss was $15.8 million for the quarter ended June 30, 2025, compared to $13.9 million for the quarter ended June 30, 2024.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of June 30, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements through the end of the third quarter of 2026.

About Vilastobart

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety and tolerability of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

On August 14, 2025 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2025 (Press release, HCW Biologics, AUG 14, 2025, View Source [SID1234655302]).

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On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, "We are pleased to have completed a successful $5.0 million equity offering in a challenging market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder." Dr. Wong continued, "Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our novel TRBC drug discovery and development platform."

On June 24, 2025, HCWB received formal notice from Nasdaq confirming that the Company has satisfied the requirements of the Equity Rule. On May 13, 2025, the Company received formal notice from Nasdaq that it regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5). Therefore, the Company now meets all Nasdaq Capital Market listing requirements for continued listing, and these matters are closed.

Business Highlights

Business Development Transactions

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On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025.
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On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which should enhance the persistence of CAR-Ts in patients.
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The Company has launched a search for a strong commercial partner for the clinical development of its T-cell engager compounds. The Company believes that its T-cell engagers target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors.

Financing Transactions

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On May 15, 2025, the Company completed a $5.0 million offering with a single institutional investor for an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit includes two warrants, which may be exercised to purchase common stock at $7.45 per share.
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On May 7, 2025, the Company extinguished $6.9 million of debt through restructuring the debt or conversion to equity. As a result, the Company strengthened its balance sheet and completed an important element of its compliance plan with all Nasdaq Listing Rules.

Clinical Development and Preclinical Results

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The Company remains on track to initiate the HCW9302 clinical trial in the third quarter of 2025. This trial is a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments.
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The Company identified compounds created with the Company’s novel TRBC platform for clinical development: Second-Generation T-Cell Engagers and Second-Generation Immune Checkpoint Inhibitors. The Company’s T-cell engager compounds target tissue factor, which is a proven solid tumor antigen. The second-generation immune checkpoint inhibitors are the Company’s candidates as a potential gateway to the multi-billion-dollar immune checkpoint inhibitors product market. The Company’ has identified its pembrolizumab-based fusion molecule as its lead candidate because in preclinical IND-enabling studies this compound exhibits potent anti-pancreatic cancer activities.

Second Quarter 2025 Financial Results

Revenues: Revenues for the first quarters ended June 30, 2024 and 2025 were $618,854 and $6,550, respectively. Revenues for the six months ended June 30, 2024 and 2025 were $1.7 million and $11,615 million, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the second quarter of 2025, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time, the Company plans to identify a new corporate partner who wishes to license HCW9206.

Research and development (R&D) expenses: R&D expenses for the first quarters ended June 30, 2024 and 2025 were $2.0 million and $1.2 million, respectively, a decrease of $802,362, or 40%. R&D expenses for the six months ended June 30, 2024 and 2025 were $4.2 million and $2.7 million, respectively, a decrease of $1.5 million, or 35%. R&D expenses were comparatively lower in 2025 primarily due to a decline in manufacturing and material and preclinical expenses.

General and administrative (G&A) expenses: G&A expenses for the first quarters ended June 30, 2024 and 2025 were $1.6 million and $2.1 million, respectively, an increase of $503,826, or 31%. G&A expenses for the six months ended June 30, 2024 and 2025 were $3.2 million and $4.3 million, respectively, an increase of $1.1 million, or 36%. The increase in G&A expenses in 2025 was primarily related to an increase in fees for professional services, accretion of a fixed bonus payable upon Maturity Date to Secured Noteholders and insurance costs. Professional services include legal fees in the ordinary course of business, accounting advisors, auditing and tax services, facilities administrative costs, expenses related to maintaining our listing on Nasdaq and remaining in compliance with SEC filings, and other expenses.

Legal expenses and recoveries, net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. For the three and six months ended June 30, 2024, preparations for the hearing and the hearing took place, along with subsequent negotiations for settlement, and the Company incurred legal fees of $10.4 million and $14.8 million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.3 million legal fees which remain unpaid.

Net loss: Net loss for the second quarters ended June 30, 2024 and 2025 were $15.3 million and $1.9 million, respectively. Net loss earnings for the six months ended June 30, 2024 and 2025 were $22.7 million and $4.1 million, respectively.

Financial Guidance

As of June 30, 2025, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan, especially business development programs, that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had early success in completing key elements of our multi-step financing plan, however, we cannot be assured that we will continue to have success with remaining elements of our plan.

On August 14, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported positive data from a retrospective analysis of the CNSide Cerebrospinal Fluid (CSF) Assay Platform at the 2025 Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) CNS Metastases Conference in Baltimore, Maryland (Press release, Plus Therapeutics, AUG 14, 2025, View Source [SID1234655320]).

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The presentation, titled "The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor," was a retrospective, multi-center analysis of 613 CNSide assays ordered by 19 physicians from 5 institutions at 2 health systems for 218 individual patients. 74% of the patients were female and the cancers most analyzed were breast (n=105) and lung (n=65). The research was presented by Priya U. Kumthekar, M.D., Professor of Neurology and Medicine at Northwestern University.

Data Demonstrated:

CSF tumor cells detected in 67% (412/613) patients using CNSide;
66 patients underwent 2 or more CSF draws; 24 patients underwent 5 or more;
20% (13/66) of patients were found to have a flip in immunocytochemistry (ICC) detection; and
88% (58/66) of patients were found to have a flip in FISH probe detection.
"The CNSide CSF Assay Platform can be used to detect gene amplification on CSF tumor cells of patients with LM and, therefore, may provide therapeutic insights to specifically target the LM tumor," said Priya U. Kumthekar, M.D., "Further, longitudinal CSF tumor cell analysis using CNSide may provide insights to modify treatment of the LM tumor over time."

The data builds upon previously announced results, "CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease," from the prospective FORESEE study, which was also presented by Dr. Kumthekar, principal investigator. The study met key primary and secondary endpoints and showed that the CNSide CSF Assay platform influenced clinical management decisions in over 90% of LM cases. Further the CNSide CSF Assay demonstrated 2.8 times the diagnostic sensitivity versus standard CSF cytology.

About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases.

About Leptomeningeal Metastases
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, but the actual incidence may be higher as it can be difficult to diagnose. Postmortem studies show the frequency of LM to be around 20% or more, highlighting healthcare providers’ need for more sensitive diagnostic options.

On August 14, 2025 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended June 30, 2025 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2025, View Source [SID1234655303]).

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"During our second quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "We have now finalized our study protocol, and we expect to initiate our Phase 2b clinical study of IKT-001, our re-engineered prodrug of imatinib mesylate, in PAH in the second half of 2025."

Multiple studies including both Phase 2 and the Phase 3 IMPRES study previously demonstrated that imatinib mesylate ("imatinib"), an anti-proliferative tyrosine kinase inhibitor, was highly efficacious in PAH. Notably in the IMPRES study, patients that maintained 400 mg of imatinib for greater than 50% of the treatment period showed a placebo adjusted 45-meter improvement in 6-minute walk distance ("6MWD") which represents best-in-class improvements for patients afflicted by PAH. More recently, a contemporary study in the American Journal of Respiratory and Critical Care Medicine demonstrated that higher exposures of imatinib were associated with a larger improvement in total pulmonary resistance ("TPR"). The 400 mg dose of imatinib exhibited the greatest impact on TPR and, even though the majority of patients completed the study at 200 mg or less, the magnitude of the hemodynamic change for the study was noted to compare favorably with recent studies of novel therapies added to background treatment. The Company believes this supports its thesis that IKT-001 has the potential to minimize GI side effects while maximizing the highly efficacious outcomes observed at 400 mg across multiple studies.

Recent Developments:

Advancement of IKT-001 as a therapy in PAH:
During the first half of 2025, the Company evaluated potential study designs and obtained feedback from various key opinion leaders before finalizing a clinical study protocol for its forthcoming Phase 2b study, known as IMPROVE-PAH.
IMPROVE-PAH is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. The Company’s bioequivalence studies previously confirmed that 500 mg of IKT-001 has comparable exposure in humans to 380 mg of imatinib. The primary efficacy endpoint is change in pulmonary vascular resistance at Week 26. Secondary endpoints include 6MWD, World Health Organization functional class, and pharmacokinetics. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least 50 patients at 12-weeks of follow-up.
The Company expects to initiate IMPROVE-PAH in the second half of 2025.
Financial Results

Cash Position: As of June 30, 2025, cash, cash equivalents and marketable securities were $87.7 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the quarter ended June 30, 2025, was $9.9 million, or $0.11 per share, compared to a net loss of $5.0 million, or $0.66 per share in the quarter ended June 30, 2024. Net loss for the six months ended June 30, 2025, was $23.6 million, or $0.26 per share, compared to a net loss of $9.6 million, or $1.38 per share, for the six months ended June 30, 2024.

R&D Expenses: Research and development expenses were $5.3 million for the quarter ended June 30, 2025, compared to $3.1 million for the quarter ended June 30, 2024. Research and development expenses were $15.8 million for the six months ended June 30, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $1.0 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $5.8 million for the six months ended June 30, 2024.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2025 were $5.9 million, compared to $2.0 million for the quarter ended June 30, 2024. Selling, general and administrative expenses for the six months ended June 30, 2025 were $11.2 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $4.0 million for the six months ended June 30, 2024.